Invivyd announces FDA alignment on BLA pathway for COVID-19 antibody

WALTHAM, Mass. - Invivyd, Inc. (NASDAQ:IVVD), a $95 million market cap biotech company, announced Thursday it has received FDA guidance on a potential Biologics License Application (BLA) pathway for its monoclonal antibody candidate VYD2311, intended for COVID-19 prevention. According to InvestingPro data, the company’s stock has seen significant volatility, declining over 50% in the past six months despite maintaining a strong balance sheet with more cash than debt.

According to the company’s press release, the FDA advised that a single Phase 2/3 randomized, double-blind, placebo-controlled trial could support a BLA submission for VYD2311. The primary endpoint would measure reduction in RT-PCR-confirmed symptomatic COVID-19, with analysis planned at 12 weeks. The company boasts impressive gross profit margins of 93%, though InvestingPro analysis indicates it’s currently burning through cash at a notable rate.

The antibody candidate is being developed for adults and adolescents 12 years and older weighing at least 40kg, including immunocompromised individuals. The company aims to position VYD2311 as an alternative to vaccines for COVID-19 prevention.

"We believe monoclonal antibodies such as VYD2311 can serve as a powerful alternative to vaccines for COVID-19 prevention," said Marc Elia, Chairman of Invivyd’s Board of Directors, in the press release.

The FDA recommended evaluating two doses of VYD2311 to assess differences in protection levels and safety profiles. Invivyd also plans to include a head-to-head safety comparison with COVID-19 vaccines, pending regulatory alignment.

The company stated that VYD2311 shares a molecular lineage with pemivibart, Invivyd’s antibody that received emergency use authorization for pre-exposure prophylaxis in certain immunocompromised patients.

Invivyd reported that VYD2311 demonstrated high SARS-CoV-2 antiviral titers and favorable safety in its first-in-human study. The company indicated it has quantities of VYD2311 clinical supply and potential commercial launch product available.

The antibody is designed for intramuscular administration and has an observed half-life of approximately 76 days, according to the company. While currently unprofitable, analysts tracked by InvestingPro expect the company to turn profitable this year, with projected sales growth ahead. For deeper insights into Invivyd’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

In other recent news, Invivyd, Inc. announced that its COVID-19 monoclonal antibody candidate, VYD2311, demonstrated a favorable safety profile in a Phase 1/2 clinical trial. The study involved 40 subjects and evaluated various administration routes, with all adverse events classified as mild to moderate. In related developments, H.C. Wainwright reiterated a Buy rating for Invivyd, setting a $5.00 price target after positive data on VYD2311’s long half-life and safety profile. Additionally, Invivyd has formed the SPEAR Study Group to explore the benefits of monoclonal antibodies for Long COVID and Post-Vaccination Syndrome, enlisting experts like Dr. Michael Peluso and Dr. Amy Proal. Yale School of Medicine Professor Akiko Iwasaki has joined this initiative, bringing her expertise in viral pathogenesis and human immunobiology. The company’s strategic priorities and commercial performance were recently discussed at the HCW 3rd Annual BioConnect Conference, where analysts engaged with Invivyd’s management.

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